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| Sponsor: | Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00571480 |
Purpose
Ear acupuncture can be used as a treatment for pregnancy induced low back pain.
| Condition | Intervention |
|---|---|
|
Pregnancy Related Low Back Pain |
Other: acupuncture Other: Sham acupuncture Other: standard of care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Acupuncture and Low Back Pain During Pregnancy |
| Enrollment: | 159 |
| Study Start Date: | February 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 true acupuncture
acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain
|
Other: acupuncture
ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
Other Name: retained ear acupuncture treatment
|
|
Sham Comparator: 2
three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy
|
Other: Sham acupuncture
ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
Other Name: retained ear acupuncture treatment
|
|
3
standard of care
|
Other: standard of care
participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
Other Name: standard of care
|
Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low back pain can be debilitating for pregnant women but there is lack of effective treatment. Owing to the unique circulation system between mother and fetus, prenatal care providers and gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal of this clinical investigation is to determine whether ear acupuncture can be used as treatment for this special clinical entity. The participants are randomized into one of the three interventions based on a computer generated randomization table. These three interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture. All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest and topical warm/cold compress. The participants in group 1 & 2 received a total of three continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand in preselected ear acupuncture points for one week then after day 7. All participants are followed/observed for a total 2 weeks after the initiation of the study.
Eligibility| Ages Eligible for Study: | 13 Years to 46 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Shu-Ming Wang, M.D., Yale University |
| ClinicalTrials.gov Identifier: | NCT00571480 History of Changes |
| Other Study ID Numbers: | HIC 12291, 5 R21 AT001613-03 |
| Study First Received: | December 10, 2007 |
| Last Updated: | July 17, 2009 |
| Health Authority: | United States: Institutional Review Board |
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auricular acupuncture pregnancy related low back pain acupuncture |
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Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |